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通过热挤出而不是溶剂造制备的可溶性薄膜
Mathieu Reuther1, Nicolas Rollet2, Frédéric Debeaufort3
1AdhexPharma, 42-44 Rue de Longvic, 21300 Chenôve, France; Univ. Bourgogne Franche-Comté, L'Institut Agro, Université Bourgogne Europe, INRAE, UMR PAM 1517, 21000 Dijon, France.
International journal of pharmaceutics
|March 31, 2025
概括
这项研究比较了口腔可分散膜 (ODF) 的溶剂造和热挤出. 热挤出是一种有前途的无溶剂方法,用于工业ODF生产,尽管薄膜特性存在微小的差异.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
背景情况:
- 口腔可分散膜 (ODF) 提供方便的药物输送.
- 制造方法对ODF的特性和稳定性有很大的影响.
- 优化ODF生产对于制药应用至关重要.
研究的目的:
- 为了比较ODF制造的溶剂造和热挤出.
- 评估每种方法生产的ODF的物理,化学和功能性质.
- 评估ODF在不同湿度条件下的长期稳定性.
主要方法:
- 采用了溶剂造和热挤出技术.
- 口腔可分散膜 (ODF) 包含一种难以溶解的活性药物成分 (API).
- 电影的特点是分解,溶解,物理属性,化学稳定性和抗拉强度.
主要成果:
- 这两种方法都产生了符合药品标准的ODF,用于分解和溶解.
- 溶剂造产生了更加均和灵活的薄膜.
- 热挤出导致薄膜稍微脆,但表现出优越的长期结构和化学完整性,特别是在不透气的包装中.
结论:
- 热挤出是一种可行的,无溶剂的替代工业ODF生产.
- 热挤出需要仔细优化配方和工艺参数.
- 环境效益和适应性使热挤出成为现代制药制造业的吸引力.
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